FDA: Smokeless Tobacco Warning Stays

Petition denied for a "less harmful" message on packaging.

The FDA denied a petition by two tobacco companies to ease up on the warnings around smokeless tobacco.

R.J. Reynolds and the American Snuff Company had requested that the FDA change one of the four warning statements required for product packages and advertising from "This product is not a safe alternative to cigarettes" to "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

A supplement to the petition suggested "No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes" as an alternative.

Regardless of whether people might read the current label as saying smokeless tobacco isn't a safer alternative, it is factual as written because no tobacco product is safe, the agency argued.

The petition didn't ask for a formal modified risk designation, which no tobacco product has yet received.

Snus-maker Swedish Match was the first to be considered for that designation. It had asked for a similar change to the labeling for its smokeless tobacco product as well as removal of warnings about oral cancers, tooth loss, and gum disease. However, an FDA advisory panel last month was skeptical of recommending any change. The FDA has not yet made a final decision on that application.

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